KYTHERA Biopharmaceuticals Inc has entered into separate license agreements with Actelion Pharmaceuticals Ltd and the University of Pennsylvania for a novel approach to the treatment of hair loss.
Under the terms of the agreement with Actelion, KYTHERA Holdings Ltd licensed the worldwide rights to setipiprant, a clinical-stage selective and potent oral antagonist to the prostaglandin D2 (PGD2) receptor. As part of the agreement, Actelion will be eligible to receive up to $27 million in potential development and regulatory milestones, as well as royalties on sales if setipiprant is successfully commercialized.
Under the terms of the agreement with the University of Pennsylvania, KYTHERA Holdings Ltd acquired exclusive worldwide rights to certain patent rights owned by the University of Pennsylvania covering the use of PGD2 receptor antagonists for the treatment of hair loss under a license agreement facilitated by the Penn Center for Innovation.
The discovery of the relationship between PGD2 and hair loss was made in the laboratory of George Cotsarelis, MD, at the University of Pennsylvania and published in late 2011. KYTHERA has been supporting this research for the last 2 years under sponsored research and option agreements to further develop and elucidate the initial reported observations.
“These observations are potentially the most innovative new thinking in hair loss over the last 2 decades. Setipiprant is believed to directly affect this hair loss pathway, and our own preclinical and in vitro human hair models confirmed this effect,” says Frederick Beddingfield, III, MD, PhD, KYTHERA’s chief medical officer, in a news release. “It is a well-characterized molecule with a large safety database, and we believe we can quickly initiate a development program to study it in hair loss. Putting these two pieces of the puzzle together is ideal and represents an example of our approach to scientifically sound and efficient drug development.”
KYTHERA plans to conduct a human proof-of-concept study to establish the efficacy of setipiprant in male subjects with androgenic alopecia (AGA).
Kythera’s submental fat melting candidate—ATX-101 (deoxycholic acid)—is currently slated for review by the Dermatology and Ophthalmic Drugs Advisory Committee of the US Food and Drug Administration.